Continued process verification ensures pharmaceutical manufacturing stays in control through data analysis, trend detection, ...

Process validation (PV) is the collection and evaluation of data from the process design stage through commercial production that establishes scientific evidence that a manufacturing process is ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

General Considerations for Process Validation - Stage 3 Continued Process Verification. A Review of EU Annex 15 and its Comparison to FDA's Process Validation Guidance.

Process validation plays a critical role in the success for a new biopharmaceutical on the path of commercialization, including the crucial process characterization. As a program advances towards ...

In new guidance, Process Validation: General Principles and Practices, the FDA updates the venerable Guideline on General Principles of Process Validation published in 1987.

“The successful validation of the production process at commercial scale is the result of a significant facility expansion and scale-up that more than tripled the Company’s capacity to ...

Particles for Humanity has successfully completed process validation for the commercial-scale manufacturing of PFH-VAP, the company's lead product. This novel, dry powder, vitamin A formulation is ...

ValGenesis Smart GxP™ is the first AI-enabled platform purpose-built to unify validation and process development across the product lifecycle. Featuring five integrated applications—ValGenesis ...

Girindus has won its second process validation contract this year. The process is for the manufacture of an oligonucleotide currently in Phase III testing. It has been granted orphan drug status ...